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Coronavirus pandemic

No difference in immunity in men, women inoculated with Sputnik V, manual says

Neither does the safety profile in the group of individuals over 60 years of age differ from the general population of patients, according to the vaccine developer

© Pyotr Kovalyov/TASS

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Putin’s Covid vaccine delay doesn’t undermine trust in Russian vaccine, Kremlin says

MOSCOW, December 28. /TASS/. Clinical trials of the Sputnik V vaccine have demonstrated that the immunity level to the coronavirus does not differ in men and women. This information was included in the instruction manual on the medical use of the vaccine preparation published on the website of the Federal Service for Surveillance in Healthcare.

"Immunological properties and the safety of the vaccine were studied in various clinical trials on adult volunteers of both genders aged over 18. The interim analysis of the immunogenicity demonstrated that the vaccine forms an immune response in volunteers. <...> Levels of antibodies did not meaningfully vary in men and women <...>, no statistically significant difference in volunteers of different gender and age was detected," the document reads.

Also, since the Russian Healthcare Ministry approved the use of the Sputnik V vaccine in elderly persons, the updated instruction manual does not contain age restrictions for people over 60. "The data obtained during clinical trials with the participation of patients of this age group proved that the introduction of the developed vaccine induces a formation of a strong immune response to the SARS-CoV-2 virus involving both humoral and cellular immunity chains in people over 60 years of age. At the same time the safety profile in the group of individuals aged over 60 does not differ from the general population of patients. Taking into account the obtained results, the corresponding results were approved," the letter by Director of the Gamaleya National Research Center Alexander Gintsburg to healthcare specialists on issues of regulatory aspects of use of Sputnik V reads.

On August 11, Russia became the first country worldwide to register a vaccine against the coronavirus which was named Sputnik V. The preparation was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry and passed clinical trials in June-July. Post-registration trials began in Moscow on September 7, the first vaccine was administered to volunteers on September 9.

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